JOURNEY II XR 74013987Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556696026), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K173331); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2018Fracture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING KEEL PREPARATION WITH NEW XR PUNCH THE PROXIMAL MEDIAL TIBIA FRACTURED. THIS IS A LATE REPORT DUE TO THE EVENT WAS REPORTED TO THE COMPLAINT'S DEPARTMENT AFTER 30 DAYS OF AWARE BY THE COMPANY SALES REPRESENTATIVE.

  Patient problems: Injury; No Code Available

  MAUDE report 7721157 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173331. One submission often covers many models, so check the product and lot details in each record.

• Z-1044-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1045-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1042-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi
• Z-1043-2019 · Dec 10, 2018 · Terminated
  JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibi